Drug · FAERS side-effect profile with label screen
Borate side effects: what 161 FDA adverse event reports show
Drug class
Not stated in label
Label matched
Sodium Borate (Borax)
closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match
Who reports
161 reports · 99% serious · 17 with death outcome · 94% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Condition listed above or as directed by a physician.
FDA label, Indications and Usage
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Reporting / coding artifact 6No label text to screen 34
What the badges mean
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
- No label text to screen No validated FDA label was retrievable for this product, so the screen could not run. Disproportionality only.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 10 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Joint injury | 98 | 599.6 529.4–679.2ROR 1,530.8 · χ² 57,759 / p <1e-300 | 534.2 EB05 451.2 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 451.4 · 93% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 101 | 596.1 528.8–672.0ROR 1,598.0 · χ² 59,203 / p <1e-300 | 533.1 EB05 451.4 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 353.2 · 93% clinician | no trial data cached |
| Vaginal discharge | 32 | 416.2 305.0–567.9ROR 519.2 · χ² 12,807 / p <1e-300 | 332.3 EB05 246.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=32 · 97% clinician | no trial data cached |
| Joint stiffness | 82 | 408.3 350.6–475.3ROR 831.0 · χ² 32,844 / p <1e-300 | 371.6 EB05 308.8 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 431.7 · 94% clinician | no trial data cached |
| Macular degeneration | 32 | 350.7 257.0–478.4ROR 437.4 · χ² 10,787 / p <1e-300 | 289.3 EB05 214.5 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 220.0 · 97% clinician | no trial data cached |
| Oral candidiasis (oral thrush) | 32 | 321.1 235.4–438.1ROR 400.5 · χ² 9,876 / p <1e-300 | 268.9 EB05 199.4 · IC025 +5.2 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 261.6 · 97% clinician | no trial data cached |
| Paraesthesia oral | 32 | 290.6 213.0–396.5ROR 362.5 · χ² 8,934 / p <1e-300 | 247.2 EB05 183.3 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 301.9 · 97% clinician | no trial data cached |
| Therapy non-responder | 98 | 287.0 253.5–324.9ROR 731.8 · χ² 27,639 / p <1e-300 | 271.2 EB05 229.0 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious PRR 272.8 · 93% clinician | no trial data cached |
| Musculoskeletal pain | 101 | 249.5 221.4–281.1ROR 667.8 · χ² 24,766 / p <1e-300 | 237.8 EB05 201.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 231.9 · 93% clinician | no trial data cached |
| Therapeutic product effect incomplete | 111 | 204.8 184.6–227.2ROR 657.1 · χ² 22,344 / p <1e-300 | 197.5 EB05 168.6 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 224.2 · 94% clinician | no trial data cached |
| Neoplasm malignant | 101 | 197.5 175.3–222.5ROR 528.3 · χ² 19,584 / p <1e-300 | 190.2 EB05 161.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.5 · 93% clinician | no trial data cached |
| Arthropathy | 83 | 194.1 167.0–225.5ROR 399.5 · χ² 15,768 / p <1e-300 | 185.6 EB05 154.4 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 137.7 · 93% clinician | no trial data cached |
| Folliculitis | 14 | 176.7 107.1–291.7ROR 193.5 · χ² 2,272 / p <1e-300 | 142.6 EB05 90.3 · IC025 +3.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 120.9 | no trial data cached |
| Flank pain | 12 | 167.2 97.0–288.3ROR 180.6 · χ² 1,818 / p <1e-300 | 132.4 EB05 80.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 127.6 | no trial data cached |
| Deformity | 12 | 166.9 96.8–287.8ROR 180.3 · χ² 1,815 / p <1e-300 | 132.2 EB05 80.6 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 111.3 | no trial data cached |
| Contraindicated product administered | 38 | 164.3 124.4–217.0ROR 214.7 · χ² 6,006 / p <1e-300 | 151.7 EB05 115.4 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 119.1 · 95% clinician | no trial data cached |
| Atelectasis | 12 | 161.4 93.6–278.2ROR 174.3 · χ² 1,754 / p <1e-300 | 128.7 EB05 78.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 95.0 | no trial data cached |
| Frequent bowel movements | 32 | 155.1 113.7–211.5ROR 193.3 · χ² 4,746 / p <1e-300 | 141.9 EB05 105.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 139.3 · 97% clinician | no trial data cached |
| Treatment failure | 97 | 154.1 135.9–174.7ROR 386.1 · χ² 14,641 / p <1e-300 | 149.4 EB05 126.1 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 172.5 · 93% clinician | no trial data cached |
| Procedural pain | 32 | 150.9 110.6–205.8ROR 188.0 · χ² 4,616 / p <1e-300 | 138.4 EB05 102.6 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 151.3 · 97% clinician | no trial data cached |
| Musculoskeletal stiffness | 101 | 150.2 133.3–169.2ROR 401.4 · χ² 14,867 / p <1e-300 | 146.0 EB05 123.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.0 · 93% clinician | no trial data cached |
| Tenderness | 12 | 149.8 86.9–258.3ROR 161.8 · χ² 1,627 / p <1e-300 | 121.3 EB05 73.9 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious n=12 | no trial data cached |
| Bursitis | 13 | 140.5 83.4–236.6ROR 152.7 · χ² 1,663 / p <1e-300 | 116.7 EB05 72.6 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 96.3 | no trial data cached |
| Nodule | 13 | 129.8 77.1–218.7ROR 141.2 · χ² 1,535 / p <1e-300 | 109.3 EB05 68.0 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 108.1 | no trial data cached |
| Hand deformity | 13 | 129.5 76.9–218.2ROR 140.8 · χ² 1,531 / p <1e-300 | 109.1 EB05 67.9 · IC025 +3.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 82.0 | no trial data cached |
| Helicobacter infection | 10 | 127.9 70.1–233.1ROR 136.3 · χ² 1,134 / p 5e-249 | 103.2 EB05 59.9 · IC025 +3.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 78.7 | no trial data cached |
| Quality of life decreased | 13 | 126.1 74.9–212.5ROR 137.1 · χ² 1,491 / p <1e-300 | 106.7 EB05 66.4 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 90.5 | no trial data cached |
| Therapeutic product effect decreased | 40 | 117.5 89.8–153.7ROR 156.0 · χ² 4,509 / p <1e-300 | 111.3 EB05 85.2 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 135.1 · 98% clinician | no trial data cached |
| Joint range of motion decreased | 12 | 117.0 67.9–201.7ROR 126.4 · χ² 1,266 / p 1e-277 | 99.0 EB05 60.3 · IC025 +3.4 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 86.9 | no trial data cached |
| Colitis | 32 | 110.7 81.2–151.0ROR 138.0 · χ² 3,374 / p <1e-300 | 103.9 EB05 77.1 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 69.4 · 97% clinician | no trial data cached |
| Drug intolerance | 80 | 108.3 92.7–126.6ROR 214.4 · χ² 8,433 / p <1e-300 | 105.6 EB05 87.6 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 102.9 · 92% clinician | no trial data cached |
| Joint swelling | 99 | 107.1 94.8–121.1ROR 276.6 · χ² 10,353 / p <1e-300 | 104.9 EB05 88.7 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 107.6 · 93% clinician | no trial data cached |
| Colitis ulcerative | 34 | 99.4 73.7–133.9ROR 125.7 · χ² 3,217 / p <1e-300 | 94.2 EB05 70.5 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.2 · 97% clinician | no trial data cached |
| Ulcer | 12 | 98.2 56.9–169.2ROR 106.0 · χ² 1,059 / p 1e-232 | 85.2 EB05 51.9 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 72.1 | no trial data cached |
| Rectal haemorrhage | 32 | 96.7 70.9–131.9ROR 120.5 · χ² 2,941 / p <1e-300 | 91.5 EB05 67.9 · IC025 +4.7 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 60.4 · 97% clinician | no trial data cached |
| Inflammation | 37 | 93.9 70.8–124.7ROR 121.7 · χ² 3,315 / p <1e-300 | 89.7 EB05 67.9 · IC025 +4.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 73.1 · 97% clinician | no trial data cached |
| Conjunctivitis | 13 | 92.2 54.7–155.3ROR 100.2 · χ² 1,084 / p 6e-238 | 81.5 EB05 50.7 · IC025 +3.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 99.6 | no trial data cached |
| Infection | 100 | 90.4 80.1–102.0ROR 236.9 · χ² 8,806 / p <1e-300 | 88.8 EB05 75.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.2 · 93% clinician | no trial data cached |
| Infusion related reaction (reaction during infusion) | 43 | 84.8 65.7–109.6ROR 115.4 · χ² 3,488 / p <1e-300 | 81.8 EB05 63.3 · IC025 +4.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 62.4 · 98% clinician | no trial data cached |
| Photophobia (light sensitivity) | 12 | 83.8 48.6–144.4ROR 90.4 · χ² 900 / p 4e-198 | 74.2 EB05 45.2 · IC025 +3.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 79.1 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Therapeutic product effect incomplete | 111 | 204.8 184.6–227.2ROR 657.1 · χ² 22,344 / p <1e-300 | 197.5 EB05 168.6 · IC025 +6.4 3/3 methods agree | Reporting / coding artifact | serious PRR 224.2 · 94% clinician | no trial data cached |
| Musculoskeletal stiffness | 101 | 150.2 133.3–169.2ROR 401.4 · χ² 14,867 / p <1e-300 | 146.0 EB05 123.6 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 143.0 · 93% clinician | no trial data cached |
| Neoplasm malignant | 101 | 197.5 175.3–222.5ROR 528.3 · χ² 19,584 / p <1e-300 | 190.2 EB05 161.0 · IC025 +6.3 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 117.5 · 93% clinician | no trial data cached |
| Musculoskeletal pain | 101 | 249.5 221.4–281.1ROR 667.8 · χ² 24,766 / p <1e-300 | 237.8 EB05 201.4 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 231.9 · 93% clinician | no trial data cached |
| Hepatotoxicity (liver damage) | 101 | 596.1 528.8–672.0ROR 1,598.0 · χ² 59,203 / p <1e-300 | 533.1 EB05 451.4 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 353.2 · 93% clinician | no trial data cached |
| Infection | 100 | 90.4 80.1–102.0ROR 236.9 · χ² 8,806 / p <1e-300 | 88.8 EB05 75.2 · IC025 +5.6 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 66.2 · 93% clinician | no trial data cached |
| Joint swelling | 99 | 107.1 94.8–121.1ROR 276.6 · χ² 10,353 / p <1e-300 | 104.9 EB05 88.7 · IC025 +5.8 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 107.6 · 93% clinician | no trial data cached |
| Therapy non-responder | 98 | 287.0 253.5–324.9ROR 731.8 · χ² 27,639 / p <1e-300 | 271.2 EB05 229.0 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious PRR 272.8 · 93% clinician | no trial data cached |
| Joint injury | 98 | 599.6 529.4–679.2ROR 1,530.8 · χ² 57,759 / p <1e-300 | 534.2 EB05 451.2 · IC025 +6.9 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 451.4 · 93% clinician | no trial data cached |
| Treatment failure | 97 | 154.1 135.9–174.7ROR 386.1 · χ² 14,641 / p <1e-300 | 149.4 EB05 126.1 · IC025 +6.1 3/3 methods agree | Reporting / coding artifact | serious PRR 172.5 · 93% clinician | no trial data cached |
| Arthropathy | 83 | 194.1 167.0–225.5ROR 399.5 · χ² 15,768 / p <1e-300 | 185.6 EB05 154.4 · IC025 +6.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 137.7 · 93% clinician | no trial data cached |
| Joint stiffness | 82 | 408.3 350.6–475.3ROR 831.0 · χ² 32,844 / p <1e-300 | 371.6 EB05 308.8 · IC025 +6.5 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 431.7 · 94% clinician | no trial data cached |
| Drug hypersensitivity | 81 | 54.3 46.6–63.4ROR 108.4 · χ² 4,225 / p <1e-300 | 53.7 EB05 44.6 · IC025 +5.0 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 88.2 · 93% clinician | no trial data cached |
| Drug intolerance | 80 | 108.3 92.7–126.6ROR 214.4 · χ² 8,433 / p <1e-300 | 105.6 EB05 87.6 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious PRR 102.9 · 92% clinician | no trial data cached |
| Rheumatoid arthritis | 64 | 73.8 61.0–89.2ROR 121.8 · χ² 4,543 / p <1e-300 | 72.2 EB05 58.5 · IC025 +5.1 3/3 methods agree | No label text to screen label has no adverse-reaction text | serious PRR 52.5 · 97% clinician | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Borate?
In FDA FAERS, the most frequently co-reported reaction terms for Borate are musculoskeletal stiffness, neoplasm malignant, musculoskeletal pain, hepatotoxicity, infection, joint swelling. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Borate have an FDA boxed warning?
No. The FDA label retrieved for Borate has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Borate causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 2c24fcda-dcf9-41be-9788-10833d53ab38, effective 20240123; matched on
openfda.generic_name.exact:"SODIUM BORATE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 50 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.